FDA aims to speed up arrival of complex generic drugs

Reuters Staff

3 Min Read

WASHINGTON (Reuters) - The U.S. Food and Drug Administration on Monday announced a series of measures designed to speed to market generic versions of complex drugs such as Mylan NV’s emergency EpiPen in an effort to address the rising cost of pharmaceuticals.

The measures, announced in a blog post by Commissioner Scott Gottlieb, stray into an area that has not previously been the FDA’s purview: drug prices. The agency has typically made its decisions based on safety and efficacy without regard to cost.

Gottlieb said the measures are designed to increase competition in the market by enabling generic competition to complex drugs, something he has long argued for.

“Drug access is a matter of public health concern,” Gottlieb said. “We know that enabling more generic competition, where Congress intended, helps reduce prices, enable more access, and improve public health.”

Complex drugs include medicines like metered-dose inhalers to treat asthma that have at least one feature difficult to copy under existing rules, such as complex active ingredients or formulations, which means those drugs can face less competition.

FILE PHOTO: Dr. Scott Gottlieb testifies before a Senate Health Education Labor and Pension Committee confirmation hearing on his nomination to be commissioner of the Food and Drug Administration on Capitol Hill in Washington, D.C., U.S. April 5, 2017. REUTERS/Aaron P. Bernstein

“In some cases, costly, branded drugs that are complex drugs have lost their exclusivity but are subject to no generic competition,” Gottlieb said.

President Donald Trump has raised the issue of high drug prices, especially early in his presidency, but to date little action has been taken.

Mylan, which faced an uproar over the escalating price of the EpiPen last year, culminating in a congressional hearing, has itself complained about delays getting its own versions of complex drugs onto the market, including its copy of GlaxoSmithKline Plc’s Advair asthma treatment.

Gottlieb’s stance on complex generics extends a broader shift by the FDA away from a simple consideration of safety and effectiveness. Under pressure from members of Congress it is now also taking into account broader social implications, especially in relation to its opioid drug approvals.

Gottlieb sees increasing competition in the pharmaceuticals market as a matter of public health.

“If consumers are priced out of the drugs they need, that’s a public health concern that FDA should address,” he said.